On the Cleanliness of Different Oral Implant Systems: A Pilot Study
https://www.ncbi.nlm.nih.gov/pubmed/31443535
Dirk U. Duddeck 1,2,*, Tomas Albrektsson 3, Ann Wennerberg 4, Christel Larsson 5 and Florian Beuer 6
1 Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, University Charité Berlin, 14197 Berlin, Germany
2 CleanImplant Foundation, Research Department, 10117 Berlin, Germany
3 Department of Biomaterials, Institute for Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, 40530 Gothenburg, Sweden
4 Department of Prosthodontics, Institute of Odontology, The Sahlgrenska Academy, University of Gothenburg, 40530 Gothenburg, Sweden
5 Department of Prosthodontics, Faculty of Odontology, Malmö University, 20506 Malmö, Sweden
6 Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, University Charité Berlin, 14197 Berlin, Germany
Received: 16 July 2019; Accepted: 19 August 2019; Published: 22 August 2019
Abstract: (1) Background: This paper aimed to compare the cleanliness of clinically well-documented implant systems with implants providing very similar designs. The hypothesis was that three well-established implant systems from Dentsply Implants, Straumann, and Nobel Biocare were not only produced with a higher level of surface cleanliness but also provided significantly more comprehensive published clinical documentation than their correspondent look-alike implants from Cumdente, Bioconcept, and Biodenta, which show similar geometry and surface structure.
(2) Methods: Implants were analyzed using SEM imaging and energy-dispersive X-ray spectroscopy to determine the elemental composition of potential impurities. A search for clinical trials was carried out in the PubMed database and by reaching out to the corresponding manufacturer.
(3) Results: In comparison to their corresponding look-alikes, all implants of the original manufacturers showed—within the scope of this analysis—a surface free of foreign materials and reliable clinical documentation, while the SEM analysis revealed significant impurities on all look-alike implants such as organic residues and unintended metal particles of iron or aluminum. Other than case reports, the look-alike implant manufacturers provided no reports of clinical documentation.
(4) Conclusions: In contrast to the original implants of market-leading manufacturers, the analyzed look-alike implants showed significant impurities, underlining the need for periodic reviews of sterile packaged medical devices and their clinical documentation.
Keywords: dental implants; surface properties; titanium; materials testing; implant contamination; implant surface; scanning electron microscopy; energy-dispersive X-ray spectrometry
